# US 11,028,130 B2 · PR13.5 promoter for robust T-cell and antibody responses > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,028,130 B2 - Document ID: US11028130B2 - Status: Granted - Kind: B2 - Application number: 15/821,035 - Filed: 2017-11-22 - Published: 2018-04-26 - Granted: 2021-06-08 - Earliest claimed: 2012-10-28 - Assignees: Bavarian Nordic A/S - Applicants: Bavarian Nordic A/S - Inventors: Robin Steigerwald; Kay Brinkmann - Web page: https://patentgrep.com/patent/US11028130B2 ## CPC - A61P 37/04: Immunostimulants - C07K 14/005: from viruses - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) - C12N 15/86: Viral vectors - C12N 15/863: Poxviral vectors, {e.g. entomopoxvirus} - A61K 2039/5256: {expressing foreign proteins} - A61K 2039/572: {cytotoxic response} - C12N 2710/24122: New viral proteins or individual genes, new structural or functional aspects of known viral proteins or genes - C12N 2710/24143: viral genome or elements thereof as genetic vector - C12N 2830/60: from viruses - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) - C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00) - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) ## Abstract The invention encompasses recombinant poxviruses, preferably modified Vaccinia Ankara (MVA) viruses, comprising a Pr13.5 promoter operably linked to a nucleotide sequence encoding an antigen and uses thereof. The invention is drawn to compositions and methods for the induction of strong CD8 T cell and antibody responses to a specific antigen(s) by administering one or more immunizations of the recombinant MVA to a mammal, preferably a human. ## Claims ### Claim 1 A method of inducing an antibody response and/or a CD8 T-cell response against a neoantigen in a human comprising administering one or more administrations of a recombinant modified Vaccinia Ankara (MVA) virus to the human; wherein the recombinant MVA comprises a Pr13.5 promoter operably linked to a nucleotide sequence encoding the neoantigen, wherein the Pr13.5 promoter comprises at least 1 copy of a first nucleotide sequence set forth in any one of SEQ ID NOs:8-27 and at least 1 copy of a second nucleotide sequence set forth in any one of SEQ ID NOs:8-27, and wherein said first nucleotide sequence and said second nucleotide sequence are separated by 20-80 nucleotides. ### Claim 2 A method of inducing an immunodominant T cell response against a neoantigen in a human comprising administering one or more administrations of a recombinant modified Vaccinia Ankara (MVA) virus to the human; wherein the recombinant MVA comprises a Pr13.5 promoter operably linked to a nucleotide sequence encoding the neoantigen, wherein the Pr13.5 promoter comprises at least 1 copy of a first nucleotide sequence set forth in any one of SEQ ID NOs:8-27 and at least 1 copy of a second nucleotide sequence set forth in any one of SEQ ID NOs:8-27, wherein said first nucleotide sequence and said second nucleotide sequence are separated by 20-80 nucleotides; and wherein the immunodominant T cell response against the neoantigen is greater than a T cell response to a poxviral antigen. ### Claim 3 (depends on 2) The method of claim 2, wherein the immunodominant T cell response is at least 2, 3, 4, or 5 fold greater than the T-cell response to the poxviral antigen. ### Claim 4 (depends on 2) The method of claim 2, wherein the poxviral antigen is B8R. ### Claim 5 A recombinant modified Vaccinia Ankara (MVA) virus comprising a Pr13.5 promoter operably linked to a nucleotide sequence encoding a neoantigen, wherein the Pr13.5 promoter comprises at least 1 copy of a first nucleotide sequence set forth in any one of SEQ ID NOs:8-27 and at least 1 copy of a second nucleotide sequence set forth in any one of SEQ ID NOs:8-27, and wherein said first nucleotide sequence and said second nucleotide sequence are separated by 20-80 nucleotides. ### Claim 6 (depends on 1) The method of claim 1, wherein said first nucleotide sequence and said second nucleotide sequence are separated by 30-40 nucleotides. ### Claim 7 (depends on 2) The method of claim 2, wherein said first nucleotide sequence and said second nucleotide sequence are separated by 30-40 nucleotides. ### Claim 8 (depends on 5) The recombinant MVA of claim 5, wherein said first nucleotide sequence and said second nucleotide sequence are separated by 30-40 nucleotides.